Duloksetin STADA 45 mg tvrde želučanootporne kapsule
| Name | Duloksetin STADA 45 mg tvrde želučanootporne kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-866130875 |
| Active Substance | duloksetinklorid |
| Composition | jedna tvrda želučanootporna kapsula sadrži 45 mg duloksetina (u obliku duloksetinklorida) |
| Pharmaceutical Form | Želučanootporna kapsula, tvrda |
| Manufacturer | STADA Arzneimittel AG, Bad Vilbel, Njemačka
STADA Arzneimittel GmbH, Beč, Austrija Centrafarm Services B.V., Breda, Nizozemska Clonmel Healthcare Ltd., Clonmel, Co. Tipperary, Irska |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 28.09.2022 |
| MA Period of Validity | 28.09.2027 |
| Classification Number | UP/I-530-09/21-01/56 |
| Registration Number | 381-12-01/38-22-06 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N06AX21 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
